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Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients (VIDD) (VIDD)

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ClinicalTrials.gov Identifier: NCT03768232
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Matteo Di Nardo, Bambino Gesù Hospital and Research Institute

Brief Summary:
evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing mechanical ventilation therapy

Condition or disease Intervention/treatment
Respiratory Failure Respiratory Distress Syndrome Mechanical Ventilation Complication Other: ultrasound asessment

Detailed Description:

Physician will perform US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.

Exposure to and duration of continuous NMBA infusion during the course of MV and use of CS will be recorded.

Ventilator logs and arterial gas analysis will be checked at the time of each US measurement to ascertain ventilator settings and SBF for the 24 hours preceding each US measurement.

Extubation success will be defined as no requirement for reintubation within 48 hours following extubation. The use of NIV immediately after extubation will be decided by the physician in charge according to the patient clinical history (presence of withdrawal syndrome, ect) and NOT according to DTF measurement.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020



Intervention Details:
  • Other: ultrasound asessment
    US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.


Primary Outcome Measures :
  1. measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient [ Time Frame: through study completion an average of 100 days ]
    the assessment of the actual occurrence rate of VIDD in a population of PICU patients undergoing MV for acute respiratory failure of various etiology


Secondary Outcome Measures :
  1. evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient [ Time Frame: through study completion an average of 100 days ]
    evaluation of the impact of VIDD and clinical outcomes of our patients in terms of Mechanical Ventilation free days

  2. evaluation of two different diaphragmatic thickening fraction formula (DTF) [ Time Frame: through study completion an average of 100 days ]
    evaluate the feasibility and clinical applicability of our formula for the calculation of DTF (mTdi-insp - mTdi-exp)/mTdi-med x 100, comparing it to the standard one (Tdi-insp - Tdi-exp)/Tdi-exp x 100.

  3. evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient [ Time Frame: through study completion an average of 100 days ]
    evaluation of the impact of VIDD and clinical outcomes of our patients, in terms of MV free days, PICU length of stay (LOS) - days



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patient admitted in PICU
Criteria

Inclusion Criteria:

  • patients younger than 18 years old
  • expected clinical requiring of invasive MV for more than 36 hours

Exclusion Criteria:

  • neonates
  • subjects with preexisting diagnoses of neuromuscular weakness
  • diaphragm paresis
  • chronic respiratory failure with ongoing requirement for invasive MV, or continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or with likely death within 48 hours.

Publications of Results:

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Responsible Party: Matteo Di Nardo, Principal investigator, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT03768232     History of Changes
Other Study ID Numbers: 001
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matteo Di Nardo, Bambino Gesù Hospital and Research Institute:
ultrasound assessment
diaphragm disfuncion

Additional relevant MeSH terms:
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Critical Illness
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases